Dermatochalasis
Conditions
Keywords
dermatochalasis, bimatoprost, blepharoplasty
Brief summary
Topical bimatoprost has been shown to cause periorbital changes of soft tissue which are most pronounced when used directly onto the cornea for the treatment of glaucoma. Changes are primarily felt to be the result of prostaglandin-mediated adipocyte loss, resulting in deepening of the upper eyelid sulcus and recession of infraorbital pseudoherniation. Use of topical bimatoprost to the upper eyelid margin, now FDA approved for eyelash enhancement, may provide a metered effect on the periocular tissues and allow for a topical approach to periocular rejuvenation. This is a proof of concept study which aims to enroll a series of patients with mild to severe dermatochalasis, treat with topical bimatoprost 0.03% solution to the upper lid margin, and evaluate for cosmetic improvement of the periocular area.
Detailed description
Perception of beauty in the periocular region is influenced by several factors, including symmetry, population norms, and skin texture and tone. Soft tissue and skin changes over time create an aged appearance with the development of dermatochalasis, blepharoptosis, lacrimal gland prolapse, and fat prolapse. Techniques for periocular rejuvenation are well established and include soft tissue augmentation, resurfacing, and surgical correction. In May 2015, Sarnoff and Gotkin reported a case of chemical blepharoplasty achieved with topical bimatoprost ophthalmic 0.03% solution applied to the upper eyelid margin. After three months of use, the author noted a more youthful appearance of the periocular region, with deepening of the upper eyelid sulcus, reduction in dermatochalasis, and diminution of the inferior eyelid fat pad. These changes were attributed to the prostaglandin associated periorbitopathy (PAP), a well described phenomenon observed with the use of topical prostaglandin analogues use for glaucoma. Periorbital changes observed with topical prostaglandin analogues are primarily due to effects on aponeurotic and deep orbital adipocytes. Prostaglandins activate the adipocyte mitogen-activated protein kinase (MAPK) pathway, leading to inactivation of peroxisome proliferator-activated receptor (PPAR)-gamma, inhibition of adipocyte differentiation, and decreased fat accumulation within adipocytes. Bimatoprost concentration-dependent contractions of ciliary muscles and activation of matrix metalloproteinases may also contribute to periocular changes. Patients using topical ophthalmic prostaglandin analogues commonly develop periorbital fat loss, which has been well characterized in the ophthalmology literature. Bimatoprost applied to the upper eyelid margin for eyelash enhancement attempts to capitalize on the desirable effects of darker, longer, thicker eyelashes, while limiting more significant and undesirable effects through limited exposure of the drug to ocular tissues. This same concept may apply for dermatochalasis: at a metered dose, topical bimatoprost to the lid margin could lead to subtle periorbital fat loss resulting in improved dermatochalasis.
Interventions
Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
Sponsors
Allergan
Tulane University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18+, * mild to severe dermatochalasis, desire for enhanced eyelashes.
Exclusion criteria
* Patients with current use of ophthalmic prostaglandin analogues, * history of blepharoplasty, * history of neuromodulators or fillers to the periocular region or frontalis in the last 6 months, * existing deep upper eyelid sulcus, * opposition to eyelash enhancement, * pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graded Change in Dermatochalasis | At 12 weeks | Patients were followed for 12 weeks total, with visits every 4 weeks for a total of 4 visits. Photodocumentation was performed at each visit. At completion of the study period, each patient's photographs at weeks 0 and 12, were graded by 2 blinded evaluators for level of dermatochalasis: -1 (deep upper eyelid sulcus), 0 (no dermatochalasis), 1 (mild, slightly noticeable), 2 (moderate, noticeable), or 3 (severe, distinctive). The change of dermatochalasis (week 12 score subtracted from week 0 score) was the primary outcome measure. A greater change (based on a higher score) in dermatochalasis indicated better response to the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Satisfaction | Weeks 0, 12 | Entry and exit surveys were completed about self perception of the periocular area. The satisfaction was measured based on 2 short surveys. Entry survey had 1 question how do you rate your satisfaction with your appearance? - the scale was 0-5, with 0 being Not at all to 5 being extremely. The exit survey posed two questions, (1) how do you rate satisfaction with your appearance? with the same 0-5 scale, as well as (2) Do you notice an improvement in your eyelid droop (dermatochalasis)? with a scale as follows: Worse (-1), No Change (0), 25% better (1), 50% better (2), 75% better (3), or 100% better (4). The change in satisfaction was measured by the summation of scores from both surveys and the average was calculated. |
Countries
United States
Participant flow
Pre-assignment details
One patient enrolled in the study but was lost to followup. Data was incomplete for this subject so was not included in final analyses.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Patients received Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping) | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Continuous | 57 years |
| Race/Ethnicity, Customized Ethnicity African American | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Caucasian | 14 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 7 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Graded Change in Dermatochalasis
Patients were followed for 12 weeks total, with visits every 4 weeks for a total of 4 visits. Photodocumentation was performed at each visit. At completion of the study period, each patient's photographs at weeks 0 and 12, were graded by 2 blinded evaluators for level of dermatochalasis: -1 (deep upper eyelid sulcus), 0 (no dermatochalasis), 1 (mild, slightly noticeable), 2 (moderate, noticeable), or 3 (severe, distinctive). The change of dermatochalasis (week 12 score subtracted from week 0 score) was the primary outcome measure. A greater change (based on a higher score) in dermatochalasis indicated better response to the treatment.
Time frame: At 12 weeks
Population: Patients received Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group | Graded Change in Dermatochalasis | .2679 units on a scale |
Secondary
Change in Patient Satisfaction
Entry and exit surveys were completed about self perception of the periocular area. The satisfaction was measured based on 2 short surveys. Entry survey had 1 question how do you rate your satisfaction with your appearance? - the scale was 0-5, with 0 being Not at all to 5 being extremely. The exit survey posed two questions, (1) how do you rate satisfaction with your appearance? with the same 0-5 scale, as well as (2) Do you notice an improvement in your eyelid droop (dermatochalasis)? with a scale as follows: Worse (-1), No Change (0), 25% better (1), 50% better (2), 75% better (3), or 100% better (4). The change in satisfaction was measured by the summation of scores from both surveys and the average was calculated.
Time frame: Weeks 0, 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group | Change in Patient Satisfaction | .214 units on a scale |